Astellas Reports Sustained GA Reduction With Long-Term IZERVAY Treatment In GATHER2 Extension Study

Astellas Pharma

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(RTTNews) - Astellas Pharma Inc. announced the first results from the open-label extension (OLE) of its Phase 3 GATHER2 study, revealing that monthly treatment with IZERVAY (avacincaptad pegol intravitreal solution) continues to significantly reduce geographic atrophy (GA) lesion growth in patients with GA secondary to age-related macular degeneration (AMD). The therapy demonstrated sustained efficacy for up to 3.5 years, with earlier initiation of treatment offering greater preservation of retinal tissue.

During the 18-month OLE trial, patients who had completed the initial GATHER2 study transitioned to monthly IZERVAY treatment, regardless of whether they had previously received monthly, every-other-month (EOM), or sham treatments. The extension study showed that IZERVAY reduced GA lesion growth by 37% to 40.5% compared to projected sham outcomes. Importantly, the treatment continued to be well tolerated, with no reported cases of retinal vasculitis or occlusive vasculitis, underscoring its favorable long-term safety profile.

A real-world study has provided valuable insights into the treatment patterns and safety profile of IZERVAY (avacincaptad pegol intravitreal solution) in patients with geographic atrophy (GA). The analysis, based on data from the American Academy of Ophthalmology IRIS Registry (Intelligent Research In Sight), included 10,181 patients and 13,391 eyes treated in routine clinical practice across the United States during IZERVAY's first year following FDA approval.

This retrospective observational study found no new safety signals and reported low rates of treatment discontinuation, reinforcing the safety and tolerability of IZERVAY in real-world settings. Among patients who received IZERVAY at least twice, the mean interval between injections per patient eye (n=11,799) was 7.0 weeks.

Interestingly, while 87.1% of patients had GA in both eyes, only 68.5% received IZERVAY treatment in one eye. Additionally, 22.7% of patient eyes received anti-VEGF therapy alongside IZERVAY, with nearly 90% of these having prior exposure to anti-VEGF treatment.

Adverse events were infrequent, with only 3.6% of patients (2.9% of eyes) experiencing any AE during the 25-week follow-up period. This corresponds to an event rate of 103 per 10,000 IZERVAY injections, further supporting its favorable safety profile in clinical practice.

IZERVAY is approved for the treatment of GA in the United States, Australia and conditionally in Japan. Astellas continues to engage with regulatory authorities around the world to bring ACP to GA patients globally.

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